GUEST COLUMNISTS

• FDA Issues New Guidance On Therapeutic Equivalence

  The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?

• July 2026 — CDMO Opportunities And Threats Report

  Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

• ADC CDMO Selection For Small Biotech

  Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.

• Europe's ATMP Opportunity Still Requires Local Navigation

  European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.

• The Unspoken Truth About Cell Therapy Product Understanding

  Developers often discover important attributes after it's too late to act on them. A well-designed program asks what's needed for commercialization and works backward.

• Implementing And Optimizing Your eQMS

  This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.

• Rebuilding America's Pharmaceutical Backbone Through Small-Batch Manufacturing

  Many small molecule products no longer require massive production. Instead, flexible capacity is needed that can economically produce smaller commercial volumes while maintaining quality and compliance.

• CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers

  Make smarter outsourcing decisions early. Reduce the risk of costly tech transfers, evaluate capacity needs, speed development timelines, and strengthen manufacturing partnerships.